COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Bromocriptine in the Treatment of Peripartum Cardiomyopathy (BRO-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02590601
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : September 6, 2017
Canadian Cardiovascular Society
Information provided by (Responsible Party):
Marc Jolicoeur, Montreal Heart Institute

Brief Summary:

Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young women in the puerperal period. Thus far, no specific treatment has been approved to treat this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of survivors have persistent chronic heart failure leading to disabling symptoms and decreased quality of life.

Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a central dopamine agonist known to decrease prolactin levels, might thwart its deleterious effects in women suffering from PPCM. Following this rationale, bromocriptine should improve myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes and healthcare outcomes.

Condition or disease Intervention/treatment Phase
Peripartum Cardiomyopathy Drug: Bromocriptine Other: Guideline-driven medical therapy (GDMT) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Active Comparator: Bromocriptine + Guideline-driven medical therapy

In addition to heart failure treatment described above, patients will be administered bromocriptine 2.5 mg orally twice daily for 14 days, followed by 2.5 mg orally daily for 42 days.

Although not a study procedure, we recommend anticoagulation with prophylactic doses of subcutaneous low-molecular weight heparin during the whole duration of bromocriptine therapy.

Drug: Bromocriptine
Other: Guideline-driven medical therapy (GDMT)
Guideline-driven medical therapy
New onset PPCM will be managed according to the principles of guideline-driven medical therapy for new-onset heart failure as per the position statement for treatment of PPCM published by the European Society of Cardiology (ESC) and the Canadian Cardiovascular Society (CCS) update on heart failure and pregnancy . The choices and administration of GDMT will be left at the discretion of the treating physician
Other: Guideline-driven medical therapy (GDMT)

Primary Outcome Measures :
  1. MACE [ Time Frame: 1 year ]
    MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.

Secondary Outcome Measures :
  1. Death from cardiovascular causes [ Time Frame: 5 years ]
  2. Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 6 months ]
    Recovery defined as : (proportion of patients with LVEF ≥ 54%)

  3. All-cause mortality [ Time Frame: 5 years ]
  4. Occurence of arrythmias [ Time Frame: 1 year ]
    Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation

  5. Number of all-cause hospitalisation [ Time Frame: 5 years ]
  6. Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ) [ Time Frame: 1 year ]
  7. Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF) [ Time Frame: 1 year ]
  8. Heart transplantation [ Time Frame: 5 years ]
  9. Mechanical circulatory support [ Time Frame: 1 year ]
  10. Number of hospitalisation for cardiovascular causes [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Safety adverse events [ Time Frame: 12 months ]
    Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Peripartum cardiomyopathy defined by the following criteria:

    • Development of heart failure in the last month of pregnancy or within 5 months of delivery;
    • Absence of an identifiable alternative cause of heart failure;
    • Absence of recognizable heart disease prior to the last month of pregnancy;
    • Left ventricular systolic dysfunction demonstrated by classic echocardiographic criteria, such as depressed ejection fraction;
  3. Recent onset of PPCM ( 1 month);
  4. Written informed consent.

Exclusion Criteria:

  1. Hypersensitivity or contraindication to bromocriptine;
  2. Patients already taking bromocriptine for PPCM or for another indication;
  3. Cardiogenic shock before enrolment;
  4. Survival expected to be less than 1 year due to non-cardiovascular causes (eg. cancer);
  5. Participation to another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
  6. Patients who in the opinion of the investigator will not comply with specified drugs, or follow-up evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02590601

Layout table for location contacts
Contact: Marc Jolicoeur, MD, M.Sc., MHS 514-376-3330 ext 3685
Contact: Marie-Gabrielle Lessard, RN, B.Sc. Phone: 514-376-3330 ext 2094/2

Layout table for location information
Canada, Quebec
Montreal Heart Institute Recruiting
Monteal, Quebec, Canada, H1T 1C8
Contact: Marc Jolicoeur, MD, M.Sc., MHS    514-376-3330 ext 3685   
Contact: Luc Harvey, RN    514-376-3330 ext 2776   
Principal Investigator: Anique Ducharme, MD, FRCPC         
Sponsors and Collaborators
Montreal Heart Institute
Canadian Cardiovascular Society
Layout table for investigator information
Principal Investigator: Robert Avram, MD Université de Montréal
Principal Investigator: Maxime Tremblay-Gravel, MD, MSc Université de Montréal
Principal Investigator: Guillaume Marquis-Gravel, MD, MSc Université de Montréal
Principal Investigator: Olivier Desplantie, MD CM, FRCPC Université de Montréal
Principal Investigator: Anique Ducharme, MD FRCPC Montreal Heart Institute

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marc Jolicoeur, Lead investigator, Montreal Heart Institute Identifier: NCT02590601    
Other Study ID Numbers: MP-33-2015-1874 (MP)
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Marc Jolicoeur, Montreal Heart Institute:
Peripartum cardiomyopathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action